Restrictive and/or obstructive implant for inducing weight loss

ABSTRACT

Described herein is a system for inducing weight loss in a patient, which comprises an extragastric space occupier positionable in contact with an exterior surface of a stomach wall to form an inward protrusion of wall into the stomach, and a retention device positionable in contact with the wall to retain the inward protrusion and to thereby capture the extragastric space occupier within the protrusion.

PRIORITY CLAIM

This application is a divisional of U.S. patent application Ser. No.12/765,177 filed Apr. 22, 2010, now allowed, which is a continuation ofU.S. patent application Ser. No. 11/114,400 filed Apr. 26, 2005, nowU.S. Pat. No. 7,717,843 which claims the benefit of U.S. ProvisionalPatent Application No. 60/565,378 filed Apr. 26, 2004, each of which areincorporated herein by reference in their entirety.

FIELD OF THE INVENTION

The present invention relates generally to the field of implants forinducing weight loss in patients, and specifically to devices andmethods for reducing the effective volume of a patient's stomach and orcreating restrictions to slow passage of food into the stomach.

BACKGROUND OF THE INVENTION

An anatomical view of a human stomach S and associated features is shownin FIG. 1A. The esophagus E delivers food from the mouth to the proximalportion of the stomach S. The z-line or gastro-esophageal junction Z isthe irregularly-shaped border between the thin tissue of the esophagusand the thicker tissue of the stomach wall. The gastro-esophagealjunction region G is the region encompassing the distal portion of theesophagus E, the z-line, and the proximal portion of the stomach S.

Stomach S includes a fundus F at its proximal end and an antrum A at itsdistal end. Antrum A feeds into the pylorus P which attaches to theduodenum D, the proximal region of the small intestine. Within thepylorus P is a sphincter that prevents backflow of food from theduodenum D into the stomach. The middle region of the small intestine,positioned distally of the duodenum D, is the jejunum J.

FIG. 1B illustrates the tissue layers forming the stomach wall. Theoutermost layer is the serosal layer or “serosa” S and the innermostlayer, lining the stomach interior, is the mucosal layer or “mucosa”MUC. The submucosa SM and the multi-layer muscularis M lie between themucosa and the serosa.

Prior art treatments for obesity range from diet and medication tohighly invasive surgical procedures. Some of the more successfulsurgical procedures are the vertical banded gastroplexy or the proximalgastric pouch with a Roux-en-Y anastomosis. However, known complicationsare present with each of these procedures. More successful and lessinvasive options are desired.

A less invasive prior art treatment for obesity includes implantation ofa gastric balloon delivered into the stomach via the esophagus. Theballoon is an obstructive device—it prevents overeating by occupyingvolume within the stomach. Although implantation of a gastric balloon isless invasive than other surgical procedures, gastric balloons canmigrate down the GI tract, causing obstruction and thus necessitatingremoval.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a schematic illustration of a human stomach and a portion ofthe small intestine.

FIG. 1B is a cross-sectional perspective view of a portion of a stomachwall, illustrating the layers of tissue forming the wall.

FIG. 2 is a cross-section view of a stomach illustrating positioning ofan obstructive implant.

FIG. 3 is a cross-section view of a stomach illustrating positioning oftwo obstructive implants.

FIG. 4 is a cross-section view of a stomach illustrating positioning ofan obstructive implant in the antral region of the stomach.

FIG. 5 is a cross-section view of a stomach illustrating positioning ofan obstructive implant in the fundal region of the stomach.

FIG. 6 is a cross-section view of a stomach illustrating alternativepositioning of two obstructive implants

FIG. 7 is a cross-section view of a stomach illustrating positioning ofan irregularly-shaped obstructive implant.

FIG. 8 is a cross-section view of a stomach illustrating positioning ofan elongate obstructive implant.

FIG. 9 is a cross-section view of a stomach illustrating positioning ofan obstructive implant having an alternative shape.

FIGS. 10-12A are perspective views of alternative configurations forobstructive implants. FIG. 12B illustrates the implant of FIG. 12Apositioned in the stomach.

FIGS. 13A through 13F are a sequence of drawings illustrating endoscopicimplantation of an obstructive implant. FIG. 13G is an implantation stepthat is an alternative to the step shown in FIG. 13F.

FIG. 14 is a cross-section view of a stomach illustrating use of aforce-distributing retention band with an obstructive implant.

FIG. 15 is a cross-section view of a stomach illustrating use of analternative force-distributing retention band with an obstructiveimplant.

FIGS. 16 through 18 are cross-section views of a stomach illustratingalternate retention methods for obstructive implants.

FIG. 19 illustrates an obstructive implant having a subcutaneousinflation port.

FIGS. 20 and 21 illustrate use of obstructive implants to facilitateretention of other obesity-controlling devices within the stomach.

DETAILED DESCRIPTION OF THE DRAWINGS

Referring to FIG. 2, an obstructive implant 10 includes a bodypositioned against the exterior of the stomach wall W. The implantoccupies stomach volume by causing a portion of the stomach wall W tobulge into the interior volume of the stomach, thus reducing theeffective volume of the stomach interior and reducing stomach capacity.Because the implant 10 is positioned outside the stomach, it cannotmigrate into the intestinal tract creating obstructions. A retentionband 12 is positioned within the stomach encircling a portion of thewall W so as to retain the implant 10 within pocket 2 as shown. Theretention band 12 may be a ring that is elastic or inelastic, flexibleor fairly rigid. The diameter of the retention band 12 may be adjustableif desired. The retention band 12 is preferably proportioned such thatin the event the band becomes free within the stomach, it can passthrough the intestinal system without incident. Thus, the retentiondevice is preferably of a size that will not on its own to occupysufficient space within the stomach to create feelings of satiety, butthat relies on the extragastric implant 10 to reduce stomach capacity.Nonetheless, in alternate embodiments the retention band 12 may alsoperform a space-occupying function, and/or a restrictive and/orobstructive function.

Various positions for the implant are illustrated in the drawings.Depending on the size and positioning of the implant, it may function asan obstructive device, a restrictive device, or both. In someembodiments, the implant may have an expanded volume in the range ofapproximately 200-700 cc, sufficient to cause the inwardly-protrudingpocket 2 to fill a portion of the stomach, thereby causing the patientto feel full and thus limiting food intake. In FIG. 2, the implant ispositioned to function as an obstructive device (i.e. to occupy space soas to reduce effective stomach volume), but also to create a restriction14 in the stomach. The restriction 14 is a narrowed region of thestomach, which slows the rate at which food can descend from theesophagus into the stomach. Food may accumulate in the region above therestriction, causing the patient to experience feelings of satiety andthus limiting food intake, and/or limiting the amount of food a patientcan consume at one time.

FIG. 3 shows a pair of implants 10 and a pair of retention bands 12positioned in the proximal stomach to create a restriction 14 a. Thisrestriction 14 a may also minimize reflux and thus function as treatmentfor patients suffering from gastro-intestinal reflux disease (GERD).

FIG. 4 illustrates that the implant 10 may be positioned in the antrumA. It may similarly be positioned at the pylorus P (see FIG. 1A).Alternatively, the implant 10 may be positioned in the fundus F as shownin FIG. 5 again creating an obstruction as well as an (optional)restriction 14 b in the proximal stomach. The original position of thewall of the fundus F is illustrated in dashed lines.

FIG. 6 illustrates that a pair of implants 10 may be positioned againstregions of stomach wall W1, W2 on opposite sides of the stomach. Theseimplants are retained in their respective pockets 2 using a singleretention band 12 encircling both regions of wall W1, W2 to create anobstruction within the stomach and which creates restricted flow pathson opposite sides of the obstruction.

The configuration illustrated in FIG. 6 is particularly advantageous inthat it relies in part on adhesion of the serosal tissue lining theouter surface of the stomach. It has been found that serosal tissuelayers can adhere to form relatively strong bonds when held inapposition to one another. Other embodiments including, but not limitedto, the FIGS. 2-5, 7 and 8 embodiments may be modified to allow theretention band to retain regions of serosal tissue into contact with oneanother such that over time the serosal tissue will adhere as apermanent means for retaining the implant 10. For example, if such amodification was made to the FIG. 2 embodiment, the regions R1, R2 ofstomach wall would be drawn into contact with one other, and retentionband 12 would retain that contact until the serosal layers adhered toone another. At that time, the retention band (or other retentiondevices such as sutures, staples, etc.) could be removed from thestomach, such that no device remained in the stomach interior, and theimplant remained in the protrusion formed against the exterior stomachwall. It may be further desirable in such embodiments to inflate theimplant during a later procedure performed after the serosal layers haveadhered to one another. In such embodiments, inflation may be carriedout using a needle introduced into the stomach, used to pierce thestomach wall, and then passed into an inflation port (e.g. such as port26 of FIG. 2 or valve 48 of FIG. 13G). Alternatively, the balloon may beself-sealing (similar to self-sealing tires), also allowinginflation/deflation of the balloon using a needle that pierces thestomach wall and the balloon.

A section of reinforcing and/or ingrowth-promoting material 15 (FIG. 6)may be optionally placed between serosal and/or mucosal tissue layersthat are positioned in contact with one another. The material may be asynthetic or non-synthetic mesh, porous material, slotted material, orany other material through which adhesions will form or onto whichtissue will grow. Examples include, but are not limited to,polypropylene, materials sold under the trade names Goretex or Dacron,or tissue graft material such as the Surgisis material sold by WilsonCook Medical, Inc. The material may be treated with tissue-ingrowthpromoting substances such as biologics. If such material is used, theadhesions that form between the serosal tissue layers will pass throughand/or onto the interstices of the material and serve to reinforce thebond between the tissue layers. The material may further cause somemechanical abrasion of the adjacent tissue, creating additional scartissue that would further reinforce the strength of the opposed tissue.

If adhesion of adjacent mucosal tissue surfaces is desired, modificationof the interior tissue surface may further be needed in order tooptimize adhesion of opposed regions of internal stomach tissue. Inparticular, it is believed that better adhesion of the interior wallsurfaces may be achieved when a portion of the mucosal layer of tissuelining the stomach interior is removed, such that the tissue surfacessutured in apposition to one another are serosal, sub-mucosal ormuscularis layers. It is believed that opposed layers of mucosal tissuedo not adhere together as well as opposed layers of serosal,sub-mucosal, or muscularis tissue. Surface modification methods forpromoting such tissue adhesion include cutting, ablating (using RF,laser, or chemical ablation) or abrading the mucosal surface within thestomach as indicated by dashed lines. This modification is ideallyperformed before the folds are placed in apposition. Depending on thedepth to which cutting, ablation or abrasion is performed, thesub-mucosal, musclaris, or serosal layer beneath the mucosal layer isexposed. This allows the exposed regions of tissue to be placed inapposition and causes the opposed surfaces to tightly adhere over time.

Although the implants shown in FIGS. 2-6 are illustrated as beingspherical, various other configurations may be used. For example, analternate implant 10 a shown in FIG. 7 may include a recess 16 along itssurface such that the portion of the stomach wall W following thecontour of recess 16 creates a form of pouch or reservoir 18 in thestomach within which food may accumulate. An elongate implant 10 b ofthe type shown in FIG. 8 may be used to form an elongate restriction 20while greatly reducing the effective volume of the stomach. FIG. 9 showsan implant 10 c having a modified hourglass configuration including anobstructive portion 22 that functions to bulge the stomach wall inwardlyas described in connection with earlier embodiments. A neck 24 extendingfrom the obstructive portion 22 connects with a base portion 26 thathelps to distribute forces imparted against the stomach W and preventstissue erosion and/or migration of the implant. As shown in the figure,the retention band 12 preferably seats against the stomach tissuesurrounding the neck 24.

Many other shapes beyond those shown in this application may be used forthe implant (such as for accommodating the shape of the anatomy, or forcreating a restriction or obstruction of a particular size/shape),without departing from the scope of the present invention.

There are likewise many suitable structures and materials useful for theimplant. Some structures and materials are shown and described herein,although again many others may be used without exceeding the scope ofthe present invention.

For example, the implant may be an elastic or inelastic balloon that isimplantable in a deflated state and then inflated within the body usinga gas or liquid. A balloon of this type may include a port such as port26 shown in FIG. 2. During use an inflation needle may be introducedinto the stomach, used to pierce the stomach wall, and then passed intothe port 26. The needle may be used to introduce inflation medium intothe balloon, or to deflate the balloon if adjustments in balloon sizeare needed. Alternatively, the balloon may be self-sealing (along thelines of puncture-proof or self-sealing tires), also allowinginflation/deflation of the balloon using a needle that pierces thestomach wall and the balloon. This latter embodiment is advantageous inthat it does not necessitate a particular orientation for the balloon aswould be needed to orient an inflation port for receipt of an inflationneedle.

Other configurations besides balloons are also suitable for the implant.The implant 10 d may have fluted walls 28 as shown in FIG. 10, or it maybe formed of a mesh 30 as shown in FIG. 11. These implants 10 d, 10 emay be self-expanding or they may be provided in a fully expanded form.The implant 10 f of FIG. 12A includes a pair of plates 32 separated by aneck 34. When positioned as shown in FIG. 12B, a portion of the stomachwall W caves into the gap 36 between the plates 32, creating a flow pathfor food moving from the esophagus E into the stomach. The amount ofrestriction provided by the implant 10 f may be selected by selecting asuitable length or width for the neck 34.

The implant need not be a hollow structure, but could instead beentirely solid.

The implant may be implanted endoscopically using tools passed into thestomach via the esophagus. According to the endoscopic approach, theimplant is inserted into the stomach and then passed through an openingformed in the stomach wall. Alternatively, a laparoscopic method may beused to pass the implant into the abdominal cavity through incisions ortrocar punctures in the skin. The implant may also be introduced usingan open surgical approach. In both the laparoscopic and surgicalprocedures, the retention band 12 is preferably introducedendoscopically into the stomach.

FIGS. 13A through 13F illustrate one method of positioning an inflatableimplant using an endoscopic approach. Referring to FIG. 13A, retentionband 12 is inserted down the esophagus into the stomach using anendoscopic instrument 38. Next, the implant 10 is passed into thestomach and through the retention band 12 as shown in FIG. 13B. Implant10 is preferably compressed within a tubular instrument 40 having atissue-piercing distal end. The instrument 40 may be telescopicallydisposed within a tubular sheath 42 to prevent the instrument frominadvertently nicking surrounding tissue. Although not shown, aninflation tube extends through the instrument 40 and sheath 42 and iscoupled to an inflation port of the implant. An endoscope 44 is used tomonitor the procedure.

Referring to FIG. 13C, the tissue-piercing instrument 40 is extendedfrom its sheath and used to pierce through the stomach wall W at adesired implant location. The implant 10 is released from the instrument40 and partially inflated by passing inflation medium through theinflation tube. The tissue-piercing instrument 40 and its sheath 42 maybe removed from the stomach, leaving the inflation tube 46 (FIG. 13D)behind.

Next, tension is applied to the inflation tube 46 to pull the implant 10towards the stomach so as to create the pocket 2. This step draws theimplant 10 and the surrounding stomach wall through the retention band12 as shown in FIG. 13D. Once a sufficient amount of tissue has beendrawn through the retention band, the implant is inflated to the desiredsize as shown in FIG. 13E. The inflation tube 46 is detached from theimplant 10 and the endoscopic instrument 38 is detached from theretention band 12, leaving the implant in place as shown in FIG. 13F.The hole formed in the stomach wall may be closed using sutures or asealable gel that solidifies when placed into contact with the tissue.

Referring to FIG. 13G, it should be noted that the implant may includean inflation valve 48 that is left extending through the stomach wall.The valve 48 allows for post-implant size adjustments by allowinginflation medium to be added to or removed from the balloon using aninflation tube passed through the esophagus and attached to the valve.If removal of the balloon is required, the valve may be grasped usingendoscopic instruments to draw the balloon back into the stomach and outthe esophagus. The valve may be surrounded by a seal to prevent movementof stomach contents into the abdominal space outside the stomach. A gelof a type that will solidify when placed into contact with the stomachsurface may be used for this purpose.

The retention band 12 may take alternate forms or be replaced altogetherusing other types of structures that help to capture the implant 10 inthe pocket 2 at the implant site. FIG. 14 illustrates that thecross-sectional area of the restrictive band 12 a may be large relativeto the size of the implant so as to diffuse the forces imparted on theregion of stomach wall captured between the band 12 a and the implant 10and to thereby prevent erosion of, or damage to, the stomach tissue.FIG. 15 illustrates that a large surface-area retention liner 12 b mayalternatively be used so as to distribute forces over a broader surface.Referring to FIG. 16, the restriction ring 12 c and implant 10 may becoupled together by an inflation tube 50 extending through the stomachwall. A valve 52 is fluidly coupled to the tube 50 and allows forintroduction/removal of inflation medium using an inflation neededpassed into the stomach. The valve 52 and tube 50 facilitateexplantation of the implant using a grasping instrument inserted throughthe esophagus and into the stomach.

The retention band itself may be inflatable. Referring to FIG. 17B, theretention band may include separate inflatable chambers 54 a, 54 b eachhaving an inflation port 56 a, 56 b. The chambers 54 a, 54 b are joinedtogether to form an annular band. The upper chamber 54 a may be shapedto form a channel 58 for passage of food, as shown in FIG. 17B.

FIG. 18 illustrates that the retention band may be eliminated entirely.As shown, after the implant 10 is pulled against the stomach wall W,stomach tissue adjacent to the pocket 2 can be fastened together usingpledgets 60 (or sutures, staples, clips or other means). Over time, aphysiological response will cause the regions of serosal tissue held incontact with one another to bond together, thereby retaining the implantin the pocket 2.

Referring to FIG. 19, inflatable implant 10 may be tethered to aninflation port 62 positioned within a subcutaneous pocket in the body.If needed following implantation, an inflation needle may be insertedthrough the patient's skin and into the inflation port 62 to increase ordecrease the amount of inflation medium within the implant.

Referring to FIGS. 20 and 21, it should be noted that while the implant10 may itself provide restriction and/or obstruction, the implant 10 mayalso be used to prevent migration of a restrictive and/or obstructivedevice positioned inside the stomach. For example, device 64 of FIG. 20or device 66 of FIG. 21 may be positioned in the proximal stomach andseat against the portion of the stomach wall that protrudes inwardly asa result of implant 10.

Components of the type described herein may be supplied individually oras systems which may include various combinations of components such asimplants (e.g. implant 10), retention devices (e.g. band 12),implantation instruments, and/or instructions for use. If included,instructions for use may include instructions instructing a user toimplant the implant using methods such as any of those described above.For example, the instructions may instruct the user to create an inwardprotrusion in the stomach wall such as by positioning an instrument orthe implant against an exterior surface of the stomach wall. Theinstructions may further instruct the user to position the retentiondevice in a manner that at least partially retains the protrusion in thewall and that thus captures implant within the protrusion, externally ofthe stomach. In some embodiments where a retention band is provided, theinstructions for use may instruct the user to encircle a portion of theprotrusion in the wall with the retention band. The instructions mayinstruct the user as to laparoscopic, endoscopic, and/or open surgicalapproaches such as those described above.

Various components and methods have been described herein. Theseembodiments are given by way of example and are not intended to limitthe scope of the present invention. It should be appreciated, moreover,that the various features of the embodiments that have been describedmight be combined in various ways to produce numerous additionalembodiments.

1.-29. (canceled)
 30. A method of positioning an implant relative to a stomach, comprising: inserting an implant, in a collapsed configuration, through an esophagus and into the stomach; passing the implant through a stomach wall from an interior of the stomach to an exterior of the stomach; after passing the implant through the stomach wall, transforming the implant from the collapsed configuration to an expanded configuration; and forming an inward protrusion of the stomach wall, with the implant positioned adjacent the exterior of the stomach and within the inward protrusion.
 31. The method of claim 30, further comprising inserting a band through the esophagus and into the stomach.
 32. The method of claim 31, further comprising passing the implant through the band.
 33. The method of claim 30, further comprising, after transforming the implant from the collapsed configuration to the expanded configuration, pulling the implant against an exterior of the stomach wall to create the inward protrusion of the stomach wall.
 34. The method of claim 33, further comprising, after pulling the implant against the stomach wall to create the inward protrusion, transforming the implant to a further expanded configuration.
 35. The method of claim 30, wherein the implant includes a generally spherical shape.
 36. The method of claim 30, wherein the implant includes an elongated shape.
 37. The method of claim 30, wherein the step of transforming the implant from the collapsed configuration to the expanded configuration includes inflating the implant with an inflation medium.
 38. The method of claim 30, wherein the step of transforming the implant from the collapsed configuration to the expanded configuration includes allowing the implant to self-expand.
 39. A method of positioning an implant relative to a stomach, comprising: positioning a retention device in an interior of the stomach; positioning an implant exterior to the stomach and adjacent to an exterior of a stomach wall; moving the implant against the exterior of the stomach wall to form an inward protrusion of the stomach wall; and expanding the implant from a first configuration to a second configuration.
 40. The method of claim 39, wherein moving the implant against the exterior of the stomach wall to form the inward protrusion includes passing at least a portion of the inward protrusion through the retention device.
 41. The method of claim 39, wherein positioning the implant exterior to the stomach includes passing the implant through an esophagus, into the stomach, and through the stomach wall from the interior of the stomach to the exterior of the stomach.
 42. The method of claim 39, wherein expanding the implant occurs partially before moving the implant against the exterior of the stomach wall to form the inward protrusion and partially after moving the implant against the exterior of the stomach wall to form the inward protrusion.
 43. The method of claim 39, wherein the retention device is expandable.
 44. The method of claim 39, wherein the implant includes a port configured to receive an inflation device.
 45. The method of claim 39, wherein the implant includes a self-sealing material.
 46. A method of positioning an implant relative to a stomach, comprising: passing an implant transorally and through a wall of the stomach from an interior of the stomach to an exterior of the stomach; expanding the implant; and forming an inward protrusion of the stomach, with the implant positioned exterior to the stomach and at least partially within the inward protrusion.
 47. The method of claim 46, further comprising positioning a retention device in the interior of the stomach in contact with the inward protrusion.
 48. The method of claim 46, wherein expanding the implant includes inflating the implant with an inflation medium.
 49. The method of claim 46, wherein expanding the implant includes allowing the implant to self-expand. 